DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement filed 11/18/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
It is also noted that reference US Patent 10,065,961 is not the English equivalent to JP2016-504961 the patent is directed to a chemical application while the Japanese document is directed to a nail.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 10, 11 and 15-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Giersch et al. (US Pub 2008/0039857).
With respect to claim 10, Giersch discloses a targeting system (See figures 2, 7 and 9, 10 and 22-23 below) comprising: a distal aiming arm (fig 2, 28) including a plurality of dovetail recesses (see fig 2 below); a deflection assembly (fig 7, 56) including a dovetail assembly (see fig 7, 70) for attachment to the dovetail recesses an adjustment assembly (fig 7, 60) for adjusting a vertical position of the deflection assembly relative to the distal aiming arm, and a dovetail groove (fig 10, groove on 90) for receiving a targeting module; a targeting module (fig 22, 150) having a corresponding dovetail projection (see fig 22 below) and, the targeting module defining an opening (fig 22, 158) therethrough; and an alignment display (fig 22, 160) with markings to determine an optimal targeting position (paragraph 83) wherein the targeting module is attachable to the deflection assembly by coupling the dovetail projection with the dovetail groove (fig 23). With respect to claim 11, Giersch discloses wherein the markings on the alignment display include radiopaque measurement markings viewable on x-ray (paragraph 83). With respect to claim 15, Giersch discloses wherein the deflection assembly includes an outer casing (see fig 7 below) with a handle portion (fig 7, 54) for retaining the dovetail assembly, a base (fig 7, 90) for securing the targeting module, and a neck (fig 7, 67) for retaining the adjustment assembly. With respect to claim 16, Giersch discloses wherein the adjustment assembly includes a fine adjustment knob (see fig 7 below), the fine adjustment knob includes a rotatable knob attached to a threaded shaft (fig 7, 60, screw), which is threadedly engaged with the outer casing (threaded into 67).
PNG
media_image1.png
782
634
media_image1.png
Greyscale
PNG
media_image2.png
848
837
media_image2.png
Greyscale
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3, 4, 7, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giersch et al. (US Pub 2008/0039857) in view of Bauer (US Patent 11,806,061).
With respect to claim 1, Giersch discloses a targeting system (see figures 2, 7 and 9 below) for inserting a distal fastener (title) into an intramedullary nail (fig 2, 10), the system comprising: an intramedullary nail (fig 2, 10) having a proximal end (See fig 2 below) and a distal end (see fig 2 below) with a distal through opening (See fig 3 below); a nail insertion handle (fig 2, 22) including a coupling portion (see fig 2 below) to removably couple to the proximal end of the intramedullary nail and a handle portion (See fig 2 below); a distal aiming arm (fig 2, 28) attachable to the handle portion of the nail insertion handle, wherein the distal aiming arm includes a plurality of dovetail recesses (See fig 2 below, recesses have an internal groove for 62 and 64 forming the tail); a deflection assembly (fig 7, 56) including a dovetail assembly (fig 7, 70) for attachment to the dovetail recesses and an adjustment assembly (fig 7, 60) for adjusting vertical position of the deflection assembly relative to the distal aiming arm; a targeting module (fig 9, 84 and 74) attachable (74 is attachable) to the deflection assembly, the targeting module defining an opening (fig 9, 82 and 90) therethrough; and a sleeve (fig 13) positionable through the opening in the targeting module (as shown in figure 12), wherein the deflection assembly is adjustable to account for deflection of the intramedullary nail, thereby defining a trajectory to the distal through opening in the intramedullary nail (paragraph 71). With respect to claim 4, Giersch discloses wherein the distal aiming arm includes a plate (Fig 2, 28) with an arcuate bend (see figure 2 below) and the dovetail recesses are defined into inner and outer faces (the recesses are through holes such that they are located on both the inner (facing the nail) and the outer face of the plate) of the plate to accommodate incremental placement of the deflection assembly. With respect to claim 7, Giersch discloses wherein the targeting module includes a plurality of overlapping holes (fig 9, 88 and 90). With respect to claim 8, Giersch discloses wherein the targeting module is attached to the deflection assembly with a tenon (fig 9, 86) configured to fit within a corresponding groove (fig 9, 66) in a bottom surface (on the bottom half of the assembly) of the deflection assembly.
PNG
media_image3.png
972
792
media_image3.png
Greyscale
With respect to claim 1, Giersch disclose the claimed invention except for wherein the distal aiming arm includes a substantially planar attachment head with two mirrored connection surfaces
Bauer discloses a distal aiming arm (fig 2, 15) includes a substantially planar attachment head (fig 2, by 36) with two mirrored connection surfaces (see fig 2 below) to allow for simultaneous placement of all screws in the nail (col. 2, ll. 42-46). With respect to claim 3, Bauer discloses wherein the two mirrored connection surfaces have two angles that act in different planes (fig 2 below the surfaces are oriented to opposite sides of the bone).
PNG
media_image4.png
498
526
media_image4.png
Greyscale
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Giersch to include the distal aiming arm includes a substantially planar attachment head with two mirrored connection surfaces in view of Bauer in order to allow for simultaneous placement of all screws in the nail.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giersch as applied to claim 1 above, and further in view of Cocaign et al. (US Patent 10,357,314).
With respect to claim 5, Giersch discloses the claimed invention except for wherein each dovetail recess defines a ball detent divot configured to receive a corresponding ball detent on the deflection assembly.
Cocaign discloses a connection between a recess (fig 11B, 185) defining a ball detent divot (fig 11B, 184) configured to receive a corresponding ball detent (fig 11A, 182) on an assembly (fig 11A, 146) to provide a resilient connection (col. 11, ll. 20-25).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Giersch to include wherein each dovetail recess defines a ball detent divot configured to receive a corresponding ball detent on the deflection assembly in view of Cocaign in order to provide a resilient connection.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giersch as applied to claim 1 above, and further in view of Collazo (US Pub 2005/0187557).
With respect to claim 6, Giersch discloses a fine adjustment knob (fig 7, 60) but does not disclose a coarse adjustment button for vertically adjusting the deflection assembly the coarse adjustment button defines a threaded through opening and is retained in the neck of the casing, the threaded shaft extends through the coarse adjustment button, and in one position, the threaded shaft is engaged with the coarse adjustment button and in another position, the threaded shaft is disengaged from the coarse adjustment button.
Collazo discloses a coarse adjustment button (see fig 6 below) for vertically adjusting the deflection assembly (fig 6, 11) the coarse adjustment button defines a threaded through opening (fig 6, 62) and is retained in the neck of the casing (fig 6, 28), the threaded shaft (Fig 6, 12) extends through the coarse adjustment button, and in one position, the threaded shaft is engaged with the coarse adjustment button (as shown in fig 6) and in another position (pressing the button in direction P), the threaded shaft is disengaged from the coarse adjustment button to allow for course adjustment by sliding or fine adjustment of the threaded shaft (paragraph 14).
PNG
media_image5.png
698
496
media_image5.png
Greyscale
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Giersch to include a coarse adjustment button for vertically adjusting the deflection assembly the coarse adjustment button defines a threaded through opening and is retained in the neck of the casing, the threaded shaft extends through the coarse adjustment button, and in one position, the threaded shaft is engaged with the coarse adjustment button and in another position, the threaded shaft is disengaged from the coarse adjustment button in view of Collazo in order to allow for course adjustment by sliding or fine adjustment of the threaded shaft.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giersch as applied to claim 1 above, and further in view of Hedgeland et al. (US Pub 2019/00383326).
With respect to claim 9, Giersch discloses the claimed invention except for wherein the sleeve has a D-shaped shaft with a flat that interfaces with a retention pin in the targeting module.
Hedgeland discloses wherein the sleeve (fig 2C, 117) has a D-shaped shaft (fig 2C, 133) with a flat (133 make the flats) that interfaces with a retention pin (fig 2C, 135) in the targeting module (fig 2C, 107) to prevent accidentally releasing of the sleeve (paragraph 63).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Giersch to include the sleeve has a D-shaped shaft with a flat that interfaces with a retention pin in the targeting module in view of Hedgeland in order to prevent accidentally releasing of the sleeve.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giersch et al. (US Pub 2008/0039857) in view of Cocaign et al. (US Patent 10,357,314).
With respect to claim 12, Giersch discloses wherein the dovetail assembly includes a moveable block (fig 7, 52, 50) and a cam lock (see fig 7 below) attached to a foot (Fig 7, 58). With respect to claim 13, Giersch discloses wherein the foot includes a male dovetail projection (fig 7, 62, 64) with a planar outer surface (ends are planar) and an arched bottom surface (curved pin shape) configured to be received into one of the dovetail recesses in the distal aiming arm (as shown in figure 9). With respect to claim 14, Giersch discloses wherein the cam lock includes a cam lever (fig 7, 71) connected to the foot, an internal compression spring (see fig 7 below) which maintains preload on the foot.
PNG
media_image6.png
366
376
media_image6.png
Greyscale
With respect to claim 12, Giersch discloses the claimed invention except for the foot having a ball detent.
Cocaign discloses a foot (fig 11A, 146) having a ball detent (fig 11A, 182) to provide a resilient connection (col. 11, ll. 20-25).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Giersch to include the foot having a ball detent in view of Cocaign in order to provide a resilient connection.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Giersch et al. (US Pub 2008/0039857) in view of Collazo (US Pub 2005/0187557).
With respect to claim 17, Giersch discloses a fine adjustment knob (fig 7, 60) but does not disclose a coarse adjustment button for vertically adjusting the deflection assembly the coarse adjustment button defines a threaded through opening and is retained in the neck of the casing, the threaded shaft extends through the coarse adjustment button, and in one position, the threaded shaft is engaged with the coarse adjustment button and in another position, the threaded shaft is disengaged from the coarse adjustment button.
Collazo discloses a coarse adjustment button (see fig 6 below) for vertically adjusting the deflection assembly (fig 6, 11) the coarse adjustment button defines a threaded through opening (fig 6, 62) and is retained in the neck of the casing (fig 6, 28), the threaded shaft (Fig 6, 12) extends through the coarse adjustment button, and in one position, the threaded shaft is engaged with the coarse adjustment button (as shown in fig 6) and in another position (pressing the button in direction P), the threaded shaft is disengaged from the coarse adjustment button to allow for course adjustment by sliding or fine adjustment of the threaded shaft (paragraph 14).
PNG
media_image5.png
698
496
media_image5.png
Greyscale
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Giersch to include a coarse adjustment button for vertically adjusting the deflection assembly the coarse adjustment button defines a threaded through opening and is retained in the neck of the casing, the threaded shaft extends through the coarse adjustment button, and in one position, the threaded shaft is engaged with the coarse adjustment button and in another position, the threaded shaft is disengaged from the coarse adjustment button in view of Collazo in order to allow for course adjustment by sliding or fine adjustment of the threaded shaft.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 3-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. With respect to claim 10, the applicant argues that Giersch does not disclose a dovetail groove and a dovetail projection to connect the targeting module. The rejection above has been modified necessitated by the amendment to rely on 150 to be the targeting module which connects via a dovetail groove and projection as shown above.
The rejections are deemed proper.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.J.C/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights